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WG4 Interlaboratory Study Activities. A. Multiple interlaboratory studies are planned to support gene delivery system measurement assurance. B. WG4-ILS1 study activities are focused on physical titer measurements.
Gene Delivery Systems
Working Group 4 (WG4) efforts are focused on identifying and minimizing the sources of variability in assays of gene delivery systems including adenoviral vectors, adeno-associated viral vectors, lentiviral vectors, lipid nanoparticles and extracellular vesicles. Consensus-based methods, reference materials, and reference data are expected to be made available to the community from these efforts. Activities in progress include:
An interlaboratory study on physical titer measurement of gene delivery systems WG4 is actively planning its first interlaboratory study (WG4-ILS1) on physical titer measurements of gene delivery systems including genomic titer, capsid titer, particle concentration, and other novel and/or orthogonal physical titer methods. Future interlaboratory studies will be conducted for functional titer measurements and particle preparation purity (full/partial/empty) characterization.
International documentary standards participation Working group members are participating in the development of international documentary standards through ISO. Standards under active development with WG4 participation include: